Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21025 

Congressional decision to allow a 

broader range of physicians and treating 

practitioners to prescribe POVs. This 

increased burden is offset by the new 

payments implemented in connection 

with the Final Rule, which is 

demonstrated by the shift in 

prescriptions from one class of 

equipment, power wheelchairs, to 

another class of equipment, POVs. 

In addition, CMS believes that with 

the recent coverage decision on Mobility 

Assistive Equipment, the implementing 

details in the Final Rule (e.g. improved 

documentation for suppliers; physician 

and treating practitioner payments; 

improved classification of mobility 

equipment; the elimination of the 

certificate of medical necessity (CMN)), 

and the provider outreach and 

education provided by CMS, the DME 

program safeguard contractors (PSCs) 

and DME Medicare administrative 

contractors (MACs), the needs of 

mobility-impaired beneficiaries and the 

needs of suppliers have been better met. 

Frequency: Recordkeeping—On 

occasion; Affected Public: Business or 

for-profits, Not-for-profit institutions, 

and State, Local or Tribal governments; 

Number of Respondents: 38,000; Total 

Annual Responses: 342,000; Total 

Annual Hours: 48,600. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Home Health 

Conditions of Participation (CoP) 

Information Collection Requirements 

and Supporting Regulations in 42 CFR 

484.10, 484.12, 484.16, 484.18, 484.36, 

484.48, 484.52; Form Numbers: CMS–R–

39 (OMB#: 0938–0365); Use: The 

information collection requirements 

contained in this request are part of the 

requirements classified as the 

conditions of participation (CoPs) which 

are based on criteria prescribed in law 

and are standards designed to ensure 

that each facility has properly trained 

staff to provide the appropriate safe 

physical environment for patients. 

These particular standards reflect 

comparable standards developed by 

industry organizations such as the Joint 

Commission on Accreditation of 

Healthcare Organizations, and the 

Community Health Accreditation 

Program. The primary users of this 

information will be State agency 

surveyors, the regional home health 

intermediaries, CMS and home health 

agencies (HHAs) for the purpose of 

ensuring compliance with Medicare 

CoPs as well as ensuring the quality of 

care provided by HHA patients. 

Frequency: Recordkeeping and 

Reporting—Annually, On occasion; 

Affected Public: Business or for-profits, 

Not-for-profit institutions, and State, 

Local or Tribal governments; Number of 

Respondents: 9,354; Total Annual 

Responses: 9,354; Total Annual Hours: 

1,048,483.5. 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Health 

Insurance Common Claims Form and 

Supporting Regulations at 42 CFR Part 

424, Subpart C; Form Number: CMS–

1500(08–05), CMS–1490–S (OMB#: 

0938–0999); Use: The Form CMS–1500 

answers the needs of many health 

insurers. It is the basic form prescribed 

by CMS for the Medicare program for 

claims from physicians and suppliers. 

The Medicaid State Agencies, 

CHAMPUS/TriCare, Blue Cross/Blue 

Shield Plans, the Federal Employees 

Health Benefit Plan, and several private 

health plans also use it; it is the de facto 

standard ‘‘professional’’ claim form. 

Medicare carriers use the data 

collected on the CMS–1500 and the 

CMS–1490S to determine the proper 

amount of reimbursement for Part B 

medical and other health services (as 

listed in section 1861(s) of the Social 

Security Act) provided by physicians 

and suppliers to beneficiaries. The 

CMS–1500 is submitted by physicians/ 

suppliers for all Part B Medicare. 

Serving as a common claim form, the 

CMS–1500 can be used by other thirdparty payers (commercial and nonprofit 

health insurers) and other Federal 

programs (e.g., CHAMPUS/TriCare, 

Railroad Retirement Board (RRB), and 

Medicaid). 

However, as the CMS–1500 displays 

data items required for other third-party 

payers in addition to Medicare, the form 

is considered too complex for use by 

beneficiaries when they file their own 

claims. Therefore, the CMS–1490S 

(Patient’s Request for Medicare 

Payment) was explicitly developed for 

easy use by beneficiaries who file their 

own claims. The form can be obtained 

from any Social Security office or 

Medicare carrier. 

Since the last submission of this 

information collection request, we 

discontinued form CMS–1490U which 

was used by employers, unions, 

employer-employee organizations that 

pay physicians and suppliers for their 

services to employees, group practice 

prepayment plans, and health 

maintenance organizations. Therefore, 

this collection will no longer contain 

the CMS–1490U. 

In sum, the CMS–1500 and CMS–

1490S result in less paperwork burden 

placed on the public. The CMS–1500 

provides efficiency in office procedures 

for physicians and suppliers; the CMS–

1490S provides beneficiaries with a 

relatively easy form to use when filing 

their claims. Without the collection of 

this information, claims for 

reimbursement relating to the provision 

of Part B medical services/supplies 

could not be acted upon. This would 

result in a nationwide paralysis of the 

operation of the Federal Government’s 

Medicare Part B program, and major 

problems for the other health plans that 

use the CMS–1500, inflicting severe 

physical and financial hardship on 

providers/suppliers as well as 

beneficiaries. Frequency: Reporting—On 

occasion; Affected Public: State, Local, 

or Tribal Government, Business or 

other-for-profit, Not-for-profit 

institutions; Number of Respondents: 

1,048,243; Total Annual Responses: 

970,174,260; Total Annual Hours: 

33,067,757. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on June 26, 2007. 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development—B, Attention: 

William N. Parham, III, Room C4–26–

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: April 20, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–7955 Filed 4–26–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1387–N] 

Medicare Program; Meeting of the 

Practicing Physicians Advisory 

Council, May 21, 2007 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 


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21026 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

SUMMARY: This notice announces a 

quarterly meeting of the Practicing 

Physicians Advisory Council (the 

Council). The Council will meet to 

discuss certain proposed changes in 

regulations and manual instructions 

related to physicians’ services, as 

identified by the Secretary of Health and 

Human Services (the Secretary). This 

meeting is open to the public. 

DATES: Meeting Date: Monday, May 21, 

2007, from 8:30 a.m. to 5 p.m. e.d.t. 

Deadline for Registration without Oral 

Presentation: Friday, May 18, 2007, 12 

noon, e.d.t. 

Deadline for Registration of Oral 

Presentations: Friday, May 4, 2007, 12 

noon, e.d.t. 

Deadline for Submission of Oral 

Remarks and Written Comments: 

Wednesday, May 9, 2007, 12 noon, e.d.t. 

Deadline for Requesting Special 

Accommodations: Monday, May 14, 

2007, 12 noon, e.d.t. 

ADDRESSES: Meeting Location: The 

meeting will be held in Room 705A, 7th 

floor, in the Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201. 

Submission of Testimony: 

Testimonies should be mailed to Kelly 

Buchanan, DFO, Centers for Medicare 

and Medicaid Services, 7500 Security 

Boulevard, Mail stop C4–13–07, 

Baltimore, MD 21244–1850, or contact 

the DFO via e-mail at 

PPAC@cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Buchanan, the Designated Federal 

Official (DFO), (410) 786–6132, or email PPAC@cms.hhs.gov. News media 

representatives must contact the CMS 

Press Office, (202) 690–6145. Please 

refer to the CMS Advisory Committees’

Information Line (1–877–449–5659 toll 

free), (410) 786–9379 local) or the 

Internet at http://www.cms.hhs.gov/ 

home/regsguidance.asp for additional 

information and updates on committee 

activities. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 10(a) of 

the Federal Advisory Committee Act, 

this notice announces the quarterly 

meeting of the Practicing Physicians 

Advisory Council (the Council). The 

Secretary is mandated by section 

1868(a)(1) of the Social Security Act (the 

Act) to appoint a Practicing Physicians 

Advisory Council based on nominations 

submitted by medical organizations 

representing physicians. The Council 

meets quarterly to discuss certain 

proposed changes in regulations and 

manual instructions related to 

physicians’ services, as identified by the 

Secretary. To the extent feasible and 

consistent with statutory deadlines, the 

Council’s consultation must occur 

before Federal Register publication of 

the proposed changes. The Council 

submits an annual report on its 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) 

not later than December 31 of each year. 

The Council consists of 15 physicians, 

including the Chair. Members of the 

Council include both participating and 

nonparticipating physicians, and 

physicians practicing in rural and 

underserved urban areas. At least 11 

members of the Council must be 

physicians as described in section 

1861(r)(1) of the Act; that is, Statelicensed doctors of medicine or 

osteopathy. The remaining 4 members 

may include dentists, podiatrists, 

optometrists and chiropractors. 

Members serve for overlapping 4-year 

terms. 

Section 1868(a)(2) of the Act provides 

that the Council meet quarterly to 

discuss certain proposed changes in 

regulations and manual issuances that 

relate to physicians’ services, identified 

by the Secretary. Section 1868(a)(3) of 

the Act provides for payment of 

expenses and per diem for Council 

members in the same manner as 

members of other advisory committees 

appointed by the Secretary. In addition 

to making these payments, the 

Department of Health and Human 

Services and CMS provide management 

and support services to the Council. The 

Secretary will appoint new members to 

the Council from among those 

candidates determined to have the 

expertise required to meet specific 

agency needs in a manner to ensure 

appropriate balance of the Council’s 

membership. 

The Council held its first meeting on 

May 11, 1992. The current members are: 

Anthony Senagore, M.D., Chairperson; 

Jose Azocar, M.D.; M. Leroy Sprang, 

M.D.; Karen S. Williams, M.D.; Peter 

Grimm, D.O.; Jonathon E. Siff, M.D., 

MBA; John E. Arradondo, M.D., MPH; 

Helena Wachslicht Rodbard, M.D.; 

Vincent J. Bufalino, M.D.; Tye J. 

Ouzounian, M.D.; Geraldine O’Shea, 

D.O.; Arthur D. Snow, Jr., M.D.; Gregory 

J. Przybylski, M.D.; Jeffrey A. Ross, 

DPM, M.D.; and Roger L. Jordan, O.D. 

II. Meeting Format and Agenda 

The meeting will commence with the 

Council’s Executive Director providing a 

status report, and the CMS responses to 

the recommendations made by the 

Council at the March 5, 2007 meeting, 

as well as prior meeting 

recommendations. Additionally, an 

update will be provided on the 

Physician Regulatory Issues Team. In 

accordance with the Council charter, we 

are requesting assistance with the 

following agenda topics: 

• Post Acute Care Project. 

• National Provider Identifier (NPI). 

• Physician Quality Reporting 

Initiative (PQRI). 

• Personal Health Records. 

• Durable Medical Equipment (DME) 

Final Rule. 

• Contractor Reform Update. 

For additional information and 

clarification on these topics, contact the 

DFO as provided in the FOR FURTHER

INFORMATION CONTACT section of this 

notice. Individual physicians or medical 

organizations that represent physicians 

wishing to present a 5-minute oral 

testimony on agenda issues must 

register with the DFO by the date listed 

in the DATES section of this notice. 

Testimony is limited to agenda topics 

only. The number of oral testimonies 

may be limited by the time available. A 

written copy of the presenter’s oral 

remarks must be submitted to the DFO 

for distribution to Council members for 

review before the meeting by the date 

listed in the DATES section of this notice. 

Physicians and medical organizations 

not scheduled to speak may also submit 

written comments to the DFO for 

distribution by the date listed in the 

DATES section of this notice. 

III. Meeting Registration and Security 

Information 

The meeting is open to the public, but 

attendance is limited to the space 

available. Persons wishing to attend this 

meeting must register by contacting the 

DFO at the address listed in the 

ADDRESSES section of this notice or by 

telephone at (410) 786–6132 by the date 

specified in the DATES section of this 

notice. 

Since this meeting will be held in a 

Federal Government Building, the 

Hubert H. Humphrey Building, Federal 

security measures are applicable. As 

noted above, in planning your arrival 

time, we recommend allowing 

additional time to clear security. In 

order to gain access to the building, 

participants will be required to show a 

government-issued photo identification 

(for example, driver’s license, or 

passport), and must be listed on an 

approved security list before persons are 

permitted entrance. Persons not 

registered in advance will not be 

permitted into the Hubert H. Humphrey 

Building and will not be permitted to 

attend the Council meeting. 

All persons entering the building 

must pass through a metal detector. In 

addition, all items brought to the Hubert 


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Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21027 

H. Humphrey Building, whether 

personal or for the purpose of 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for the purpose 

of presentation. 

Individuals requiring sign language 

interpretation or other special 

accommodation must contact the DFO 

via the contact information specified in 

the FOR FUTHER INFORMATION CONTACT

section of this notice by the date listed 

in the DATES section of this notice. 

Authority: (Section 1868 of the Social 

Security Act (42 U.S.C. 1395ee) and section 

10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, 

section 10(a)).) 

Dated: April 10, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–7382 Filed 4–26–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0018] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Cells, 

Tissues, and Cellular and TissueBased Products: Establishment 

Registration and Listing; Form Food 

and Drug Administration 3356; 

Eligibility Determination for Donors; 

and Current Good Tissue Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 29, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the OMB control number 

0910–0543. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products: Establishment 

Registration and Listing; Form Food 

and Drug Administration 3356; 

Eligibility Determination for Donors; 

and Current Good Tissue Practice 

(OMB Control Number 0910–0543)—

Extension 

Under section 361 of the Public 

Health Service Act (the PHS Act) (42 

U.S.C. 264), FDA may issue and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between the 

States or possessions or from foreign 

countries into the States. As derivatives 

of the human body, all human cells, 

tissues, and cellular and tissue-based 

products (HCT/Ps) pose some risk of 

carrying pathogens that could 

potentially infect recipients or handlers. 

FDA has issued regulations related to 

HCT/Ps involving establishment 

registration and listing using Form FDA 

3356; eligibility determination for 

donors; and current good tissue practice 

(CGTP). 

Establishment Registration and Listing; 

Form FDA 3356 

The regulations in part 1271 (21 CFR 

part 1271) require domestic and foreign 

establishments that recover, process, 

store, label, package, or distribute any 

HCT/Ps, or that perform screening or 

testing of the cell or tissue donor to 

register with FDA (§ 1271.10(b)(1)) and 

submit a list of each HCT/P 

manufactured (§ 1271.10(b)(2)).Section 

1271.21(a) requires the initial 

establishment registration, and 

§ 1271.25(a) and (b) identifies the 

required initial registration and HCT/P 

listing information. Section 1271.21(b) 

requires an annual update of the 

establishment registration. Section 

1271.21(c)(ii) requires establishments to 

submit HCT/P listing updates when an 

HCT/P is changed as described in 

§ 1271.25(c). Section 1271.25(c) 

identifies the required HCT/P listing 

update information. Section 1271.26 

requires establishments to submit an 

amendment if ownership or location of 

the establishment changes. FDA 

requires the use of a registration and 

listing form (Form FDA 3356: 

Establishment Registration and Listing 

for Human Cells, Tissues, and Cellular 

and Tissue-Based Products to submit 

the required information (§§ 1271.10, 

1271.21, 1271.25, and 1271.26)). To 

further facilitate the ease and speed of 

submissions, electronic submission is 

accepted (http://www.fda.gov/cber/ 

tissue/tisreg.htm). 

Eligibility Determination for Donors 

FDA requires HCT/P establishments 

described in § 1271.1(b) to screen and 

test the donors of cells and tissue used 

in those products for risk factors for and 

clinical evidence of relevant 

communicable diseases agents and 

diseases. The documented 

determination of a donor’s eligibility is 

made by a responsible person and is 

based on the results of required donor 

screening, which includes a donor 

medical history interview (defined in 

§ 1271.3(n)), and testing (§ 1271.50(a)). 

HCT/P establishments are permitted to 

ship an HCT/P only if it is accompanied 

by documentation of the donoreligibility determination (§ 1271.55(a)). 

This requirement applies to an HCT/P 

from a donor determined to be eligible 

as well as to a product from a donor 

who is determined to be ineligible and 

made available for use under certain 

provisions. The accompanying 

documentation must contain a summary 

of records used to determine donor 

eligibility, and a statement whether, 

based on the results of the screening and 

testing of the donor, that the donor is 

determined to be eligible or ineligible. 

Records used in determining the 

eligibility of a donor, i.e., results and 

interpretations of screening and testing, 

the donor eligibility determination, the 

name and address of the testing 

laboratory or laboratories, and the name 

of the responsible person who made the 

determination and the date, must be 

maintained (§ 1271.55(d)(1)). If any 

information on the donor is not in 

English, the HCT/P establishment must 

retain the original record and the 

statement of authenticity from the 

translator (§ 1271.55(d)(2)). HCT/P 

establishments must retain the records 

pertaining to HCT/Ps at least 10 years 

after the date of administration, 

distribution, disposition, or expiration, 

whichever is latest (§ 1271.55(d)(4)). 

When a product is shipped in 

quarantine, before completion of 

screening and testing, the HCT/P 

establishment must provide the donor 

identification, a statement that the 

donor-eligibility determination is not 

completed and that the product is not to 


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